BEUDAMED
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    MULTITRACK ANGIOGRAPHIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Premier Composite Instruments

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783009927·COMPOSITE CONTACT CMI INST -MINI/SML

    BBIG

    FDA UDI
    BBig B.V.·08719616012681·8003902

    SCANLAN® Titanium Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003819·S LEGACY Mic fcp, RH, NS DG, str 0.5 mm DD pft,...

    BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    KLINIDRAPE REINFORCED SURGICAL GOWNS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SALINE 1600 ROUND BREAST IMPLANT, 525 CC

    FDA Adverse Event
    MENTOR CORP.·Product code FWM·November 3, 1994

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·March 30, 2026

    PRINEO SKIN CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OMD·March 14, 2013

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIM·March 1, 2011

    CAPTURE-R READY-SCREEN (3)

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·August 12, 2014

    SMR SYSTEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code KWT·October 21, 2025

    BD NESTABLE SHARPS COLECTOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·August 10, 2021

    AIA-2000 ST

    FDA Adverse Event
    Malfunction ·TOSOH HI-TEC, INC.·Product code KHO·March 24, 2025

    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·September 26, 2012

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024